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DINNEFORDS BABY GRIPE MIXTURE

Active substance(s): SODIUM BICARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Baby Gripe Mixture
Dinnefords Gripe Mixture
Dinnefords Baby Gripe Mixture
Dinnefords Infant Gripe Mixture
Atkinsons & Barkers Infant Gripe Mixture
Snufflebabe Gripe Mixture

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium bicarbonate 50.0mg/5ml

3

PHARMACEUTICAL FORM
Liquid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
To relieve griping pains and wind in babies

4.2

Posology and method of administration
Route of Administration: Oral
Babies one to six months
One 5m1 spoonful to be given every four hours if necessary
Babies six months to one year
Two 5m1 spoonsful to be given every four hours if necessary

This product is not recommended for babies under one month or over one year.

4.3

Contraindications
Should be used with caution in babies with cardiac problems, hypertension, impaired
renal function or peripheral or pulmonary oedema.

4.4

Special warnings and precautions for use
Do not exceed the stated dose. Seek medical advice if symptoms persist or worsen.

4.5

Interaction with other medicinal products and other forms of interaction
None known

4.6

Pregnancy and lactation
Not applicable

4.7

Effects on ability to drive and use machines
Not applicable

4.8

Undesirable effects
Excessive intake could cause hypernatraemia

4.9

Overdose
Symptoms of hypernatraemia may include drowsiness and irritability, pyrexia,
tachypnoea and hyperpnoea. In more severe instances of acute sodium overload, signs
of dehydration and convulsions may occur.
Treatment
The treatment of hypernatraemia includes repair of any dehydration present and
gradual reduction of the plasma sodium. The alkalosis if present will respond to the
treatment of hypernatraemia. At all times intensive monitoring of the electrolytes, and
patient’s circulatory and central nervous system are necessary.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Antacid

5.2

Pharmacokinetic properties
Not applicable

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to
that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sorbitol solution non-crystallising
Dill oil, terpeneless
Caraway oil, terpeneless
Propylene glycol
Nipasept
Water

6.2

Incompatibilities
None

6.3

Shelf life
24 months
After first opening: 1 month

6.4

Special precautions for storage
Store below 20ºC

6.5

Nature and contents of container
i)
Amber glass sirop bottle fitted with polypropylene EPE wadded cap
containing 100 or 140m1 of product, in printed cartons.
ii)
Clear glass sirop bottle fitted with polypropylene EPE wadded cap or
polypropylene child resistant cap containing 150m1 of product, in printed cartons.

6.6

Special precautions for disposal
Not applicable

7

MARKETING AUTHORISATION HOLDER
AYRTON SAUNDERS LIMITED
NORTH WAY
WALWORTH INDUSTRAIL ESTATE
ANDOVER
SP10 5AZ
UNITED KINGDOM

8

MARKETING AUTHORISATION NUMBER(S)
PL 16431/0096

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
3rd November 1992 / 9th December 1998

10.

DATE OF (PARTIAL) REVISION OF TEXT
June 2001

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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